Kornimate/medical-research-clean huggingface dataset:
a study to investigate how common pancreatic exocrine insufficiency (pei) is in patients with type 2 diabetes and also to investigate the uptake of a single dose of epanova® or omacor® in patients with different degrees of pei

Conditions: Diabetes Mellitus, Type 2; Exocrine Pancreatic Insufficiency

Summary: this study is a 2-part open-label, randomized, crossover, multicenter, non-therapeutic phase ii study to investigate the presence of pancreatic exocrine insufficiency (pei) in patients with type 2 diabetes mellitus (t2dm), and to investigate the pharmacokinetics (pk) of epanova® (omega-3 carboxylic acids) and omega-3-acid ethyl esters (omacor®, abbott healthcare products ltd) following a single oral dose in patients with different degrees of pei.


Eligibility criteria:
inclusion criteria: * male or female aged ≥18 years and ≤70 years, with suitable veins for cannulation or repeated venipuncture. * clinically diagnosed type 2 diabetics (american diabetes association guidelines;), on oral antibiotic drug use ≥3 months and hba1c value ≥6.5% and ≤9.0% at visit 1. * have a body mass index ≥18 kg/m2 and ≤40 kg/m2 and weigh at least 50 kg. exclusion criteria: * intolerance to omega-3 fatty acids, ethyl esters or fish. * on insulin therapy or treated with injectable glucagon-like peptide-1 (glp-1). * treated with bile acid sequestrants. * serum levels of tgs \>10 mmol/l at any time during the study.

Keywords: omega-3 carboxylic acid
troponin i level and mortality in acute abdominal surgery

Conditions: Myocardial Injury After Non-cardiac Surgery; Abdomen, Acute

Summary: the goal of this prospective cohort study is to estimate the incidence of myocardial injury after non-cardiac surgery (mins) in patients undergoing acute high-risk abdominal surgery. mins is defined as at least one increased single measurement of plasma troponin i (tni). tni-dynamic is defined as either two succeeding measurements of tni \> 59 ng/l with an increase/fall of more than 20%, or by one measurements of tni \> 59 ng/l with a succeeding measurement of tni \< 59 ng/l and a decrease of more than 50%. participants will have plasma tni measured 6-12 hours postoperatively and on each of the following four postoperative days. follow-up will be minimum one year after surgery. the aim of the study is to determine: * the incidence of mins within the first four postoperative days * the incidence of dynamic tni changes * the association between mins and dynamic tni changes respectively and all-course short-term mortality

gastrointestinal tract perforation, bowel ischemia and bowel obstruction are considered acute high-risk abdominal disorders, often requiring emergency surgery. myocardial injury after non-cardiac surgery (mins) is a frequent but often unrecognized postoperative complication. mins is associated with an increased risk of other cardiac complications and 30-day mortality. however, the literature on mins is mainly regarding patients undergoing a wide range of elective or acute surgical procedures, and we do not know if the dynamic tni-criteria used for acute myocardial injury has any association with mortality in patients with mins. this study aims to estimate the incidence of mins in patients undergoing aha surgery, and the association between the short-term mortality and mins defined as a single increased measurement of tni and as tni dynamics respectively.

Eligibility criteria:
inclusion criteria: * 18 years or older * patients undergoing acute high-risk abdominal surgery exclusion criteria: * patients with microscopic perforations in colonic diverticulitis managed with laparoscopic lavage or drainage * if further treatment postoperatively was assessed as futile and terminated immediately after surgery

Keywords: myocardial injury after non-cardiac surgery abdomen, acute troponin i myocardial injury emergency surgery
efficacy bioinductive implant for tennis elbow (lateral epicondylitis)

Conditions: Tennis Elbow; Lateral Epicondylitis

Summary: the investigators are testing the efficacy of a new, fda-approved bioinductive patch in lateral epicondylitis (tennis elbow) patients. a bioinductive patch is an implant that may foster tendon regrowth and healing following surgery. patients will be randomize into one of two groups: control and investigational. patients in the "control group" will receive the normal surgery for patients who do not respond to physical therapy, lifestyle changes, and anti-inflammatory treatment. patients in the "experimental group" will receive the same surgical treatment, with the addition of the bioinductive patch. this patch will be implanted during surgery. then, using a combination of ultrasound studies and other measures, the investigators will assess how well the patch works compared to surgery alone.

a bioinductive patch is an implant that may foster tendon regrowth and healing following surgery. patients will be randomized into one of two groups: control and investigational. all surgical patients will have failed non surgery options for 6 months (physical therapy, lifestyle changes, anti-inflammatories, injections) patients in the "control group" will receive the standard surgery (open lateral epicondylectomy) . patients in the "experimental group" will receive the same surgical treatment, with the addition of the bioinductive patch. this patch will be implanted during surgery. then, using a combination of ultrasound studies and other measures, the investigators will assess how well the patch works compared to surgery alone.

Eligibility criteria:
inclusion criteria: * diagnosis of lateral epicondylitis (tennis elbow) that has failed conservative treatment (physical therapy, activity change, anti-inflammatory treatment. exclusion criteria: * previous surgery on the currently-affected elbow.

Keywords: tennis elbow tendinopathy lateral epicondylitis bioinductive
cd-rom intervention for prostate cancer screening

Conditions: Prostate Cancer

Summary: the study populations consist of a sample of the patient population (men aged 40-79 years) of a large, group model hmo and a community sample of men age 50-79. follow-up interviews of men randomly assigned to the intervention and control groups are being conducted by telephone to assess issues related to prostate cancer screening and the men's use of the cd-rom educational intervention.

the study populations consist of a sample of the patient population (men aged 40-79 years) of a large, group model hmo and a community sample of men age 50-79. follow-up interviews of men randomly assigned to the intervention and control groups are being conducted by telephone to assess issues related to prostate cancer screening and the men's use of the cd-rom educational intervention. preliminary results are available for the first 1304 follow-up interviews (interim response rate = 26%). of 554 men randomized to receive the cd-rom, 227 (41%) reported receiving the cd-rom, and 78 (14%) used it in a computer. about 51% of these 78 men used the cd-rom once only, while 42% used it twice, and 27% shared it with someone else. most users reported learning some (44%) or a great deal (46%) of new information from the cd-rom, and most reported that it helped them organize their thoughts about screening somewhat (44%) or a great deal (28%). about 19% indicated that the cd-rom increased their uncertainty somewhat or a great deal about whether or not they want to be screened, 30% reported that the cd-rom changed their feelings about whether or not they want to be screened somewhat, and 12% reported that it changed their feelings a great deal. men who used the cd-rom had higher education, higher income, higher levels of computer usage, and were more likely to have previously had a psa test compared to non-users. no other subject characteristics were significantly related to use. using randomized group assignment in an "intention to treat" analysis, prostate cancer knowledge was significantly higher in the intervention group; there were no differences between study groups in decisional conflict or realistic expectations. however, when comparing those who did and did not use the cd-rom using multiple regression analysis and controlling for differences in age, race, education, income, insurance status, previous receipt of prostate cancer screening, and computer usage, use of the cd-rom was significantly associated with higher prostate cancer related knowledge, lower decisional conflict, and more realistic expectations about risk of dying from prostate cancer. after controlling for differences between users and non-users we found evidence that the cd-rom was effective in reducing decisional conflict, and increasing knowledge and realistic expectations related to prostate cancer screening.

Eligibility criteria:
inclusion criteria: - exclusion criteria: * prostate cancer

Keywords: screening community healt education decision making computer-assisted decision making
immunogenicity and safety of two adjuvant formulations of an egg-derived pandemic vaccine

Conditions: Healthy Subjects

Summary: several combinations of h5n1 antigen concentrations and aluminium-hydroxide adjuvant concentrations will be tested for their safety and capacity to induce a specific immune response.


Eligibility criteria:
inclusion criteria: * being healthy and ≥ 18 and ≤ 49 years of age * willing and able to give informed consent exclusion criteria: * having participated in an influenza h5 vaccine trial in the past * known to be allergic to any constituent of the vaccine * serious adverse reactions to previous (influenza) vaccination * currently participating in another clinical trial or having participated in any clinical trial in the month preceding the start of the study * using medication that influences the immune system

Keywords: immunogenicity safety adjuvanted pandemic vaccine
diabetic ketoacidosis diagnosis and management

Conditions: Metabolic Acidosis; Diabetic Ketoacidosis; Brain Edema

Summary: this is the first and only study conducted on the use of capnography in children diagnosed with dka to evaluate the initial clinical grading of dka, monitor clinical improvement, and predict complications such as brain edema.

purpose: in this study, the contribution of this non-invasive follow-up method to the management of dka and the reduction of the frequency of invasive procedures was investigated in patients diagnosed with diabetic ketoacidosis (dka) in the pediatric emergency department and followed up with capnography method: this study is a prospective clinical study. between october 2020- november 2022, etco2 and ipi follow-up of 0-18 year-old pediatric patients diagnosed with dka in the pediatric emergency service of akdeniz university medical faculty hospital was performed by capnography. dka diagnosis, grading, clinical follow-up and treatment termination criteria of the patients were determined according to the ispad 2018 diagnosis and treatment guidelines. in the study; during the clinical follow-up, changes in gcs, blood glucose, vital, blood gas and capnograph parameters were examined. demographic data were analyzed in all patients and in groups of patients who underwent dka grading. gcs, blood gas and capnograph parameters were compared in the patient groups with dka grading. diagnostic test performances of blood gas and capnograph parameters were compared to detect low gcs

Eligibility criteria:
inclusion criteria: * the study group consisted of pediatric patients aged 0-18 years who were diagnosed with diabetic ketoacidosis and applied to akdeniz university pediatric emergency department. * written consent was obtained. exclusion criteria: • who did not give written consent were not included in the study.

Keywords: type 1 diabetes mellitus (type 1 dm) diabetic ketoacidosis (dka) capnography blood gas integrated pulmonary index end tidal carbon dioxide (etco2)
effect of concomitant bladder neck incision and urethral valve ablation on surgical re-intervention rate for patients with posterior urethral valve

Conditions: Pediatric Disorder; Hydronephrosis in Children; Hydronephrosis, Secondary; Hydronephrosis Congenital; Bladder-Neck; Obstruction, Congenital; Urethral Valve; Renal Function Disorder

Summary: to determine the short-term effects of concurrent valve ablation and bladder neck incision on re-intervention rate for patients with posterior urethral valve.


Eligibility criteria:
inclusion criteria: * patients who are less than 12 years of age with presenting to the mansoura university urology and nephrology center with the diagnosis of puv will be s creended for eligibility exclusion criteria: * patients with other conditions that can potentially affect lower and upper urinary tract functions * patients who were treated with urinary diversion as vesicostomy or cutaneous ureterostomy. * patients who had primary treatment of posterior urethral valve ablation at other hospitals.

Keywords: puv bni urethral valve valve ablation bladder dysfunction
gastrointestinal tolerance of a nutritional supplement in adult patients with or at risk of malnutrition

Conditions: Gastro-Intestinal Tolerance

Summary: the purpose of this study is to evaluate the gi tolerance, palatability and compliance to a high protein energy-dense oral nutrition supplement in adult patients with or at risk of malnutrition.


Eligibility criteria:
inclusion criteria: * subject has voluntarily signed and dated informed consent form approved by independent ethics committee and provided applicable privacy authorization prior to any participation in the study. * subject is considered malnourished or at risk for malnutrition * subject has normal gi function * subject requires oral nutritional supplementation ands is willing to comply with the study protocol exclusion criteria: * subject has severe dementia, eating disorder, history of significant neurological or psychiatric disorder affecting abilities to answer questions, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures * subject has a history of diabetes * subject is currently taking antibiotics or has taken antibiotics within 1 week prior to enrollment * subject has undergone major gi surgery less than 3 months prior to enrollment * subject has active malignant disease or was treated within the last 6 months for cancer * subject has immunodeficiency disorder * subject has had a myocardial infarction within the last 3 months prior to enrollment * subject is known to be allergic to intolerant to an ingredient found in the study product * subject has an aversion to the flavor of product being tested * subject has an obstruction of the gi tract precluding ingestion or absorption of the study product, inflammatory bowel disease, gastric esophageal reflux disease, short bowel syndrome, or other major gastro-intestinal disease-causing symptoms including but not limited to uncontrollable severe diarrhea, nausea, or vomiting * subject is taking medications/dietary supplements/substances that could profoundly modulate metabolism or affect gastrointestinal motility. * participation in another study that has not yet been approved as a concomitant study by the sponsor. * subject has a clinical condition that is contraindicated with this product. * subject is pregnant.
screening for renal complications in children and young adults with major sickle cell disease

Conditions: Anemia; Sickle Cell Disease

Summary: sickle cell disease is the subject of targeted neonatal screening (carried out when one of the two parents is from an endemic country - sub-saharan africa, south-east asia, central america, the caribbean) during the guthrie test. haemolysis, which results from the abnormality of the haemoglobin, and the vascular activation it causes, are responsible for multiple organ damage. major sickle cell syndromes (msc), by several mechanisms, are responsible for a wide range of renal damage, culminating in end-stage renal failure at an average age of 45 years and with an average survival of 3 years beyond esrd. the various renal disorders are : glomerular hyperfiltration and then glomerulosclerosis; tubular dysfunction, especially proximal and distal hyposthenuria (a factor in enuresis); papillary necrosis, renal infarction, episodes of acute renal failure during vaso-occlusive crises; dysregulation of the renin-angiotensin system with early arterial hypertension and, more rarely, extra-membranous glomerulonephritis. in the early stages of these conditions, simple paraclinical tests can identify them before the appearance of specific clinical signs. in patients suffering from mds, the has (high authority of health) recommends an annual check-up carried out in a competence centre. according to the has recommendations for annual surveillance, in addition to the search for other organic complications, for renal pathology, only microalbuminuria and renal ultrasound are recommended. however, as the literature shows, microalbuminuria and ultrasound only detect some of these renal disorders and at a very late stage. a large number of publications in adults and, to a lesser degree, in children, demonstrate the correlation between the frequency of acute complications of sickle cell disease (episodes of haemolysis, etc.) and the occurrence of kidney damage.


Eligibility criteria:
inclusion criteria: - patient over 1 year old followed up in the competence centre at the nice university hospital, treated for a major sickle cell disease during the annual check-up exclusion criteria: * pregnant patients (positive urine pregnancy test) * patients with other chronic conditions * progressive cancer or kidney disease * patients who are breastfeeding

Keywords: sickle cell disease renal complication
focused ultrasound cavitation augmented with aerobic exercise

Conditions: Central Obesity

Summary: this study will determine the combine effects of focused ultrasound cavitation augmented with aerobic exercises. this research could be helpful for the patients who prefer such treatments to make a wise decision that either aerobic exercises in combination with cavitation is the better and much safer treatment option to maintain healthy life.

abdominal obesity can be treated through invasive and non-invasive procedures. the most common invasive protocol is surgical liposuction, this is mostly useful for removing large volume of fat. nonsurgical approaches included exercises and selective focus energy which target the subcutaneous adipose tissue including focused ultrasound. focus ultrasound produce cavitation which results in fat cell lysis through mechanical energy without causing any harmful effect on surrounding nerves and connective tissue. there is an increasing demand for noninvasive fat reduction methods; there is variety of physical treatments in practice for localized fat reduction such as electrical stimulation, mechanical massage, light based therapies and cold low level laser irradiation but clinically most of them failed to meet expectations. literature reported that clinically high intensity focused ultrasound (hifu) is most effective for noninvasive fat reduction therapy. ultrasound causes cavitation phenomena on fat droplet watery cytoplasm interface and eventually rupture of adipocytes and triglycerides release, this whole phenomena is caused through generation of compression and decompression cycle at specific frequency. ultrasound fat cavitation is the technique of handling obesity, specially by destroying fat and shaping a body part. there is a limited literature available on effects of aerobic exercises and focused ultrasound cavitation on obesity but there was no literature available on combine effects of both treatments. this study will determine the combine effects of focused ultrasound cavitation augmented with aerobic exercises. this research could be helpful for the patients who prefer such treatments to make a wise decision that either aerobic exercises in combination with cavitation is the better and much safer treatment option to maintain healthy life.

Eligibility criteria:
inclusion criteria: * females * overweight (asian bmi scoring) * 25 to 40 years of age * central obesity exclusion criteria: * morbidly obesity * hypertension * arthritis * musculoskeletal disorders * cardiovascular disorders
effects of olive polyphenols in fibromyalgia patients

Conditions: Fibromyalgia

Summary: to study the effects of a nutritional intervention with an olive (poly)phenol preparation in female patients with fm.

this work has studied the effects of a nutritional intervention with an olive (poly)phenol preparation in female patients with fm, analyzing the complete blood count, the biochemical, lipid and coagulation profiles as well as the inflammatory and oxidative statuses in blood samples.

Eligibility criteria:
inclusion criteria: * patients to be included in the study must be female over 18 years of age. the patients had to be previously diagnosed with fm according to the criteria of the american college of rheumatology. exclusion criteria: * other chronic diseases: diabetes mellitus, hypertension, cardiovascular disorders, cancer... * patients with grade ii obesity (body mass index ≥ 35 kg/m2). * active smokers. * pregnancy. * regular treatment with acetylsalicylic acid, estrogen, corticosteroids, antioxidants or lipid-lowering drugs. * participation in another research study.

Keywords: olive polyphenol oxidative stress inflammation coagulation pain proteomics